CLICK HERE for the meeting summary.
CLICK HERE for the meeting agenda.
CLICK HERE for a list of meeting attendees.

Meeting Objectives

• Present findings
• Identify remaining gaps that may require further exploration
• Present and obtain feedback on draft considerations to improve the successful conduct and execution of pediatric antibacterial drug trials
• Develop initial consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs

Meeting Presentations*

1. CTTI History and Methodology: ABDD Program History by Jamie Roberts
2. Pediatric Product Development in the 21st Century by Lynne Yao, M.D.
3. Public-Private Partnerships to Support Pediatric Trials by Ed Connor, MD MBE
4. Opportunities: Pediatric Trials Network by P. Brian Smith MD MPH MHS
5. Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov by Joshua Thaden, MD, PhD
6. Quantifying BPCA and PREA Submissions – Pediatric Labeling for Antibacterial and Antifungal Drugs by John Farley, MD MPH
7. PENTA-ID by Mike Sharland
8. Parental Decision Making About Enrolling Children in Clinical Trials: An In-depth Interview Study by Diane Bloom, MPH, Ph.D.
9. Investigator Perspectives by Amy Corneli, PhD, MPH
10. Findings: Perspectives from Community Providers by Rachel G. Greenberg, MD
11. Industry Perspectives by Gary Noel
12. Communicating with Parents: Approaches to Informed Consent by Breck Gamel
13. Addressing the Challenges in Neonatal Infection Studies by P. Brian Smith MD MPH MHS
14. Improving Clinical Trial Design: Meeting the Needs of Investigators by John Bradley, MD
15. Breakout Report Outs

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.